Carcinogenicity assessment

Provides information on how levels of exposure of hazardous chemicals affect human health. Covers levels of exposure to hazardous chemicals below which no adverse health effects are expected to occur in various segments of the human population. The reference dose and carcinogenicity assessments on IRIS can sen>e as guides in e >aluating potential health hazards and selecting response to alleviate a potential risk to human health. Hours 8 00 a.m. to 4 40 p.m. EST, Monday - Friday. 

EPA. 1987a. Addendum to the health assessment document for trichloroethylene Update carcinogenicity assessment for trichloroethylene. Review draft. June 1987. EPA/600/8-82/006FA. 

Drug Studies in Pediatric Patients Medical Officer s Review Statistical Review Evaluation Chemistry, Manufacturing and Controls CDER Labeling and Nomenclature Committee Clinical Pharmacology/Biopharmaceutics Microbiologist s Review Pharmacokinetics Review Carcinogenicity Assessment... 

Neither an inhalation nor an oral slope factor is currently available for monomethylhydrazine. Slope factors for 1,1-dimethylhydrazine and 1,2-dimethylhydrazine were available but have been withdrawn from the U.S. EPA Integrated Risk Information System (IRIS) (U.S. EPA 1986). For a preliminary carcinogenicity assessment, the withdrawn inhalation slope factor for 1,1-dimethylhydrazine (cited in ATSDR 1994) will be used as a surrogate for monomethylhydrazine. The assessment follows previously described methodologies (NRC 1985 Henderson 1992). 

Albert, R. E. et al., "The Carcinogen Assessment Group s Method for Determining the Unit Risk Estimate for Air Pollutants," U.S. Environmental Protection Agency, 1980. 

EPA. 1986b. Evaluation of the potential carcinogenicity of chloroform. Report by Carcinogen Assessment Group, Office of Health and Environmental Assessment, Washington, DC, to Office of... 

IRIS. 1998. Integrated Risk Information System. Carcinogenicity assessment. October 1, 1998. 

CPMP/SWP/2592 /04 Revl. Conclusions and recommendations on the use of genetically modified animal models for carcinogenicity assessment. 2004. 

EPA. 1984a. Carcinogen assessment of coke oven emissions. Washington, DC U.S. Environmental Protection Agency, Office of Health and Environmental Assessment. EPA-600/6-82-003F. NTIS No. PB84 170182. 

From Anderson (1983), based on reports of the U.S. Environmental Protection Agency, Carcinogen Assessment Group 1976-1983. 

Auer, C.M. and Gould, D.H. (1987) Carcinogenicity assessment and the role of structure-activity relationship (SAR) analysis under TSCA Section 5. Environ. Carcinog. Ecotoxicol. Rev., C5, 29-71. Auer, C.M., Nabholz, f.V. and Baetcke,... 

In 1980, the Ambient Water Quality Criteria USEPA Carcinogen Assessment Group (CAG) by using a further modified linear multistage model as well as a one-hit model, arrived at a value of 0.2 /zg/L/day as the upper 95 confidence estimate of the dose in drinking water contributing an excess lifetime risk of 1 in 1 million. 

The need for carcinogenicity assessment of a biopharmaceutical is not different than that for a conventional pharmaceutical. The need is based on an... 

Examples of product class carcinogenicity hazard identifications and assessments and ultimate risk communications for biopharmaceuticals approved in the United States for chronic use or based on potential cause for concern are provided in Table 19.4a (products without carcinogenicity assessment) and Table 19.4b (products with carcinogenicity assessment). The data are derived from publicly available regulatory assessments and product labels. Specific examples are discussed below. 

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